Direct Data Capture (DDC) and Electronic Data Capture (EDC). They sound the same. But when you dig a little deeper, you find fundamental, crucial distinctions that make a significant impact on clinical research workflows, data quality, and timelines.
What’s the Advantage of DDC and How Does it Relate to Source Data?
Understanding the advantages of DDC vs. EDC requires us to clarify the definition of eSource. But first, what do we mean by source?
Source documentation is the fountainhead of data — that initial data recording, whether it’s a digital thermometer reading, a BP entry in the electronic medical record (EMR), a paper form, or an ePRO entry. eSource in clinical trials is simply the direct digitization of source data with no intermediate steps. Collecting data in this format is better for timelines, audit tracking, accuracy, consistency, and overall data quality and visibility. eSource covers a wide variety of data types, including labs and imaging data, patient-reported data, as well as clinical data captured by site staff into a mobile device.
Clinical ink’s integrated eSource solution includes DDC, clinical outcome assessments (eCOA), patient-reported outcomes (ePRO), eConsent forms, and the direct digitization of the information collected during a clinical trial, such as physical examination findings, vital signs, ECG, and blood or urine screens. And here’s the key: These data are entered directly into the DDC software in real-time as they are collected. This is critically different from traditional EDC workflows, in which data are collected in a variety of ways during the patient visit and later transcribed into the EDC application.
Using a DDC device, site staff enter data during the moment that matters, the patient visit, so errors can be corrected and omissions flagged. Edit checks run at the point of data entry, resulting in cleaner, more complete data. Clean, complete data means fewer queries and increased productivity for sites. Eliminating the need to transcribe source data into an EDC application saves time and reduces error, and eliminates the need for source data verification (SDV) — one of the biggest burdens of study monitoring. “SDV” is something of a misnomer, considering that it is performed long after the patient visit, and all that can be verified is that the transcription is accurate.
What if There Are Existing Medical Records That Need To Be Incorporated?
In any trial, at a patient’s first visit, historical information such as medical history, laboratory, or medication data will likely need to be transferred into the research record. It’s no different when you implement DDC technology. Pre-existing information in the paper or electronic medical record, the PRO record, or elsewhere may need to be transcribed into the DDC software — the same way it would need to be transcribed into a traditional EDC. Because these initial data were, in fact, transcribed (unlike most of the DDC data), they will need to be verified. Clinical ink’s DDC allows these data to be scanned and uploaded to the eSource database, where they can be remotely verified. In contrast, new data collected will be directly captured into the electronic research record, needing neither verification nor transcription.
What About Regulations? Are Regulatory Authorities in Favor of Using eSource Data?
Over the years, regulatory authorities have discussed data capture frequently with the industry. With the advent of tools, technologies, and approaches that embrace a more direct capture of data, the FDA, the EMA, and other regulatory agencies issued eSource-related white papers and guidances, embracing this type of approach. In 2019, the EMA released a qualification opinion on eSource in which Clinical Ink’s eSource solution is identified more than 10 times in relation to its use in multiple eSource studies conducted in Europe. Throughout, the agency makes it clear that eSource via Direct Data Capture is not only acceptable — it is the preferred method for data collection.
Of course, you want to make sure your vendor can configure their systems to be compliant with applicable regulations — 21 CFR Part 11, GDPR, HIPAA, and any other relevant guidance set forth by local regulatory agencies.
These references should provide perspective:
Qualification opinion on eSource Direct Data Capture (DDC)
Guidance: Electronic Source Data in Clinical Investigations
Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials
What if I’m Not Sure About Internet Connectivity?
If internet access is unavailable for your clinical trial, you might be wondering what options you should consider when looking for the ability to carry out decentralized, home-based, or hybrid studies. DDC is ideally suited for highly mobile data collection. Devices in homes, ambulatory centers, or remote medical locations can function independently and facilitate proper study execution through well-designed workflows and edit checks that ensure the right data is collected during the patient encounter.
Then, as soon as the internet can be accessed, the data is uploaded to the web portal for review by the broader study team. This flexible data collection capability supports a wide range of study designs, from 100% virtual visits to a mix of virtual and site-based visits. Clinical ink’s DDC technology features fully integrated televisit functionality to enable data to be collected when and where it makes the most sense to the patient. At the end of the day, that’s what matters the most.
Enhance Your Studies with DDC From Clinical ink
Learn more about how Clinical ink’s DDC technology saves you time, produces cleaner data, and builds confidence in both decision-making and study conduct.
Author: Doug Pierce, President & Co-Founder, Clinical ink